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Aurobindo Receives FDA Approval for Vigabatrin for Oral Solution USP, 500mg

Published: September 30, 2021

East Windsor, N.J. –Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Vigabatrin for Oral Solution USP, 500 mg . Aurobindo Pharma’s Vigabatrin for Oral Solution USP, 500 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Sabril for Oral Solution of Lundbeck Pharmaceuticals, LLC.

Vigabatrin for Oral Solution are indicated as:

  • Adjunctive therapy for adults and pediatric patients 10 years of age and older with refractory complex partial seizures.
  • Monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age.